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FDA NDA · NDA008955

CLISTIN

Sponsor: MCNEIL

APPLICATION
NDA008955
TYPE
NDA
LATEST ACTION
1980-04-01
ROUTE
ORAL
DOSAGE FORM
ELIXIR
MARKETING STATUS
Discontinued

Products

CLISTIN · ReferenceDiscontinued
CARBINOXAMINE MALEATE 4MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · ELIXIR · ORAL

Approval history

1980-04-01Labeling · Supplement 8AP
1979-08-14Labeling · Supplement 6AP
1979-08-14Manufacturing (CMC) · Supplement 7 · standardAP
1975-08-27Labeling · Supplement 5AP
1974-12-27REMS · Supplement 4 · standardAP
1974-12-27REMS · Supplement 2 · standardAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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